Conrad Shada – FDA Warning Letter, Nov 4, 2015

On November 2-4, 2015, the FDA inspected Conrad Shada's cattle operation in Anamosa, IA, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering an adulterated steer for slaughter as food.

Specifically, on or about July 31, 2015, a steer was offered for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 4, 2015, revealed florfenicol residues of 5.73 ppm in liver tissue and 0.36 ppm in muscle tissue. These levels exceed the FDA's established tolerances of 3.7 ppm for liver and 0.3 ppm for muscle, as codified in 21 C.F.R. 556.283(b)(1)(i) and (ii). This presence of unsafe drug levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the Act.

The letter emphasizes that this is not an exhaustive list of violations and that the producer is responsible for overall compliance. Prompt corrective action is required to prevent recurrence, as failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines must be submitted to the FDA within fifteen working days of receiving the letter.